Registrar Corp

HomeMedical DevicesRegistration & Medical Device ListingsMedical Device Samples › U.S. FDA Bleeding Time Device Regulations

U.S. FDA Medical Device Bleeding Time Device Requirements

FDA Medical Device Definition: A bleeding time device is a device, usually employing two spring-loaded blades, that produces two small incisions in the patient's skin. The length of time required for the bleeding to stop is a measure of the effectiveness of the coagulation system, primarily the platelets.

Registrar Corp assists Bleeding Time Device companies with:

  • FDA Bleeding Time Device Establishment Registration
  • FDA Bleeding Time Device Listing
  • FDA Bleeding Time Device Label Requirements and Exceptions
  • FDA Bleeding Time Device Import Information
  • FDA Bleeding Time Device Detentions (Bleeding Time Device Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Bleeding Time Device Manufacturers (Bleeding Time Device Suppliers)
       - Bleeding Time Device Distributors
       - Bleeding Time Device Processors
       - Bleeding Time Device Repackers
       - Bleeding Time Device Relabelers
       - Bleeding Time Device Exporters
       - Bleeding Time Device Importers
For more information about Bleeding Time Device Medical Devices, simply click below:

U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
Home | About Us | News | Resources | Exhibitions | Seminars | Associations | Careers | Sitemap | Terms of Use © 2017 Registrar Corp
Food and Beverages | Drugs | Cosmetics | Medical Devices | Radiation-Emitting Electronic Devices | Color Additives | Tobacco